CHANNEL MEDSYSTEMS — FDA Facility Profile
CHANNEL MEDSYSTEMS is an FDA-registered facility (FEI 3012018285) located in Berkeley, CA, US. RegDataLab tracks 1 FDA inspection at this facility.
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What FDA found at this site
- Latest inspection
- Feb 1, 2019: No Action Indicated (NAI)
- Inspections on record
- 1 (1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 2, latest Mar 20, 2025
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 1, 2019 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Mar 20, 2025 | Class II | Z-1584-2025 | Brand Name: Cerene Cryotherapy Device
Product Name: DEVICE, THERMAL ABLATION… Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment… |
| May 3, 2024 | Class II | Z-1889-2024 | Brand Name: Cerene Cryotherapy Device
Product Name: DEVICE, THERMAL ABLATION… Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD… |
Facility details
- Company
- Channel Medsystems, Inc.
- Location
- Berkeley, CA (US)
- Source
- device